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Switching From Tobramycin Inhalation Treatment to Tobramycin Inhaler Treatment: The Effect on CF Patients' Adherence and Quality of Life

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ClinicalTrials.gov Identifier: NCT01749644
Recruitment Status : Unknown
Verified December 2012 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 17, 2012
Last Update Posted : December 18, 2012
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center

Brief Summary:
Pseudomonas is a common and virulent respiratory bacteria in patients with Cystic Fibrosis (CF). With time, the infection with Pseudomonas becomes chronic and very difficult to eradicate. The standard treatment of chronic Pseudomonas infection is inhaled Tobramycin which is given every other month.. Inhalation of Tobramycin was proven as an effective treatment that improves the respiratory function and reduces the concentration of bacteria in the sputum. However, inhaled treatment lasts between 15 to 30 minutes twice a day and therefore adherence is a major problem. The effect of switching from inhalation treatment to inhaler treatment on patient's adherence and quality of life has not been studied.

Condition or disease
Alteration in Quality of Life of CF Patients, Following Change of Treatment From Antibiotic Inhalation to Antibiotic Inhaler

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
CF patients with chronic pseudomonas infection



Primary Outcome Measures :
  1. Improvement in quality of life [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Difference in exacerbation events [ Time Frame: 1 year ]

    To be measured by:

    Worsening of CF symptoms such as coughing, sputum, deterioration in FEV1, all of which require hospitalization




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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
CF patients with chronic pseudomonas infection
Criteria

Inclusion Criteria:

  • Age 6 years and above, Chronic Pseudomonas infection

Exclusion Criteria:

  • Younger than 6 years; No chronic PSeudomonas infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01749644


Contacts
Contact: Ori Sarouk, MD 97235302884 ifat.sarouk@sheba.health.gov.il

Locations
Israel
Safra Children's Hospital, Sheba Medical Center Not yet recruiting
Ramat Gan, Israel
Contact: Ifat Sarouk, MD    97235302884      
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Ori Efrati, MD Safra Children's hospital, National CF Center
Principal Investigator: Ifat Sarouk, MD Safra Children's Hospital, National CF center

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01749644     History of Changes
Other Study ID Numbers: SHEBA-12-9640-OE-CTIL
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: December 18, 2012
Last Verified: December 2012

Keywords provided by Sheba Medical Center:
Cystic Fibrosis, Chronic Pseudomonas Infection, Inhaled Tobramycin

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents